| Study | Type of data | Exposure measurement | Outcome assessment | Adjustment |
|---|---|---|---|---|
| Anderson, 2020 | case control | Information on exposure to SSRIs and other potential risk factors during pregnancy were collected by standardized telephone interviews with mothers of case and control infants, conducted 6 weeks to 24 months after the EDD. | Case infants were ascertained through population-based birth-defects surveillance systems in 10 U.S. states. Controls were selected randomly from the same geographic areas. Clinical data were abstracted from medical records and classified by clinician geneticists and other clinicians. | Adjusted for maternal race/ ethnicity, prepregnancy body mass index, education, and early pregnancy smoking and alcohol use |
| Chan (Controls exposed to SSRIs), 2024 | retrospective cohort (claims database) | Study data were obtained from the Clinical Data Analysis and Reporting System, a database that contains prescribing/dispensing records. | Diagnoses of malformations were determined by pediatricians, and were ascertained using the ICD-9-CM codes from specialist outpatient and inpatient records. | Exclusion of abnormalities due to maternal infection or exposure to known teratogens. No adjustment for this group of comparison. |
| Chan (Controls unexposed, pop general), 2024 | retrospective cohort (claims database) | Study data were obtained from the Clinical Data Analysis and Reporting System, a database that contains prescribing/dispensing records. | Diagnoses of malformations were determined by pediatricians, and were ascertained using the ICD-9-CM codes from specialist outpatient and inpatient records. | Exclusion of malfo due to maternal infection or exposure to known teratogens. Adjusted for age, parity, maternal pre-existing diseases (diabetes, hypertension, epilepsy...), gestational diabetes, hypertension, placental abnormalities, caesarean delivery, preterm delivery, maternal psychiatric disorders, substance/alcohol use disorders, medications (suspected teratogens, anticonvulsivant ...)... |
| Einarson, 2009 | prospective cohort | During the initial telephone contact, details of exposure and concurrent exposures are recorded on a standardized questionnaire. | At the follow-up interview, gestational findings, fetal outcomes, and neonatal health are documented on a structured form by telephone interview with each mother. The details are then corroborated with the report of the physician caring for the baby. | No adjustment/no matching for this group of exposure (the 2 whole groups were matched for maternal age, smoking, and alcohol use). |
| Khazaie (Controls exposed to diphenhydramine), 2013 | randomized controlled trial | The subjects were randomly assigned to one of three treatment groups. Medications were self-administered 1 h before bedtime. Participants were blind to their treatment type throughout the study. | Routine obstetric care was provided by the patient's gynecologic clinic at KUMS during the study. | No adjustment. Randomisation. |
| Khazaie (Controls unexposed, sick), 2013 | randomized controlled trial | The subjects were randomly assigned to one of three treatment groups. Medications were self-administered 1 h before bedtime. Participants were blind to their treatment type throughout the study. | Routine obstetric care was provided by the patient's gynecologic clinic at KUMS during the study. | No adjustment. Randomisation. |
| Laspro, 2024 | nested case control | Gestational medication use was identified by medications, prescribed, provider-administered, or reported use by mothers at any point during pregnancy. | Oral cleft cohorts were isolated using a combination of ICD codes, from the EPIC medical records. | None. |
| Ozturk, 2016 | prospective cohort | At the first contact, initiated via gynecologists, a detailed patient history form was used to notably record all drug exposures (dose, duration and timing in pregnancy). | Each newborn baby was checked at birth for signs of problems or complications. | None |
| Palmsten a (Controls exposed to SSRIs), 2013 | retrospective cohort (claims database) | Outpatient pharmacy-dispensing data. | Medicaid enrollment information was linked to inpatient and outpatient procedures and diagnoses. Outcome validity was assessed by reviewing delivery hospital medical records for a sample of 183 women. Preeclampsia defined with ICD-9 code for preeclampsia or eclampsia (642.4x–642.7x). | No adjustment for this group of comparison. |
| Palmsten a (Controls unexposed, sick), 2013 | retrospective cohort (claims database) | Outpatient pharmacy-dispensing data. | Medicaid enrollment information was linked to inpatient and outpatient procedures and diagnoses. Outcome validity was assessed by reviewing delivery hospital medical records for a sample of 183 women. Preeclampsia defined with ICD-9 code for preeclampsia or eclampsia (642.4x–642.7x). | Adjusted for delivery year, preeclampsia risk factors (age, race/ethnicity, primiparity, diabetes, multifetal gestation, pain-related diagnosis...), depression severity proxies, other antidepressant indications, other medications, and healthcare utilization. |
| Palmsten b, 2013 | retrospective cohort (claims database) | Data of prescription. | Women with an ICD-9 code for 666.x during the admission to hospital for delivery, or within three days after the delivery date, were classified as having postpartum hemorrhage. Atonic postpartum hemorrhage only (666.1x) and inpatient postpartum hemorrhage only, also considered. | Adjusted for delivery year, age, race, multiple pregnancy, diabetes, coagulopathy, number of outpatient and inpatient mood/anxiety disorder diagnoses, other mental health disorder, pain indication, sleep disorder, anticonvulsant, benzodiazepine, aspirin, heparin, low molecular weight heparin and warfarin dispensing, and number of outpatient visits and days in hospital during baseline. |
| Yaris, 2005 | prospective cohort | Data surveyed by the interviews. | Examinations were made by obstetric ultrasound for the mothers and birth weight and height, gestational age, APGAR scores, congenital malformation and developmental problems for the babies. Periodic checks of all the babies in the neonatal period, were made the first year, and following years. | None for this group of exposure. |